Tapinarof Improves Sleep in Children With Atopic Dermatitis | Healio

For children and families grappling with the nightly challenges of atopic dermatitis (AD), a modern analysis offers promising news: tapinarof cream 1% not only eases skin inflammation but also appears to improve sleep quality. Findings presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting suggest that the cream, approved by the FDA in December 2024 for both adults and children as young as two, can lead to noticeable improvements in sleep for both young patients and their caregivers.

Early and Sustained Improvements in Sleep Scores

The research, a sub-analysis of pooled data from the ADORING 1 and ADORING 2 phase 3 trials, assessed 654 patients aged 2 to 17 years with moderate to severe AD. Researchers examined changes in sleep using the Patient-Oriented Eczema Measure (POEM) sleep subdomain scores and assessed the impact on family sleep using the Dermatitis Family Impact Questionnaire (DFI) sleep subdomain.

“In my clinical experience, severe itching and sleep disruption are especially burdensome for patients with AD, so these data have the potential of being particularly impactful,” said Druhan L. Howell, MD, adjunct professor and pediatrics program director in the department of internal medicine at the University of South Alabama. The improvements were observed at different time points depending on the age group. Children aged 2 to 6 years and 12 to 17 years showed significant improvements in POEM sleep scores as early as week 1 compared to those using a vehicle (placebo) cream. Those aged 7 to 11 years experienced improvements by week 4.

The benefits extended to family members as well. Families of patients aged 12 to 15 years receiving tapinarof cream reported significant improvements in their own sleep quality as early as week 1. Improvements were also seen in families of children aged 2 to 6 and 7 to 11 years, though these took slightly longer – appearing by week 2.

Quantifying the Impact: POEM and DFI Scores

Specifically, among children aged 2 to 6 years, those treated with tapinarof cream experienced a significantly larger imply change in POEM sleep scores compared to the vehicle group (–1.9 vs. –0.9; P < .0001). Family members in this age group also showed greater improvements in DFI sleep scores (–1.1 vs. –0.6; P = .0002). Similar trends were observed in the 7 to 11 and 12 to 17 age groups, with tapinarof cream consistently demonstrating superior improvements in both patient and family sleep scores.

Rafael Chaves Cardona, MD, head of U.S. Medical affairs and outcomes research at Organon, the manufacturer of Vtama (tapinarof cream), emphasized the broader impact of AD on families. “AD can have a significant impact on sleep, not just for children living with the condition, but also for their families,” he stated. “When a child with AD struggles through the night, parents and caregivers are often awake as well, sharing in fatigue and emotional stress associated with ongoing sleep disturbances.”

Understanding Atopic Dermatitis and Sleep Disruption

Atopic dermatitis, commonly known as eczema, is a chronic inflammatory skin condition characterized by itchy, red, and inflamed skin. The intense itching associated with AD is a primary driver of sleep disturbance, as it disrupts sleep onset and causes frequent awakenings throughout the night. The National Eczema Association provides comprehensive information on the condition, its symptoms, and management strategies.

Sleep deprivation, in turn, can exacerbate AD symptoms, creating a vicious cycle. Lack of sleep weakens the immune system, increases inflammation, and impairs the skin’s barrier function, making it more susceptible to irritation and flare-ups. This bidirectional relationship highlights the importance of addressing both the skin condition and sleep disturbances in AD management.

Tapinarof: A Novel Approach to AD Treatment

Tapinarof cream 1% is a non-steroidal topical treatment that works by modulating the aryl hydrocarbon receptor (AhR), a protein involved in immune regulation and skin barrier function. By targeting the AhR pathway, tapinarof helps to reduce inflammation and relieve the symptoms of AD. The FDA’s approval in December 2024 expanded access to this treatment option for a wider range of patients, including young children.

Dr. Howell noted that tapinarof’s favorable safety profile, combined with its potential for early and sustained symptom improvement, makes it a valuable tool for managing AD and improving quality of life for patients and their families. “In my clinical experience, when caregivers come in with young patients struggling to sleep as of symptoms of AD such as itch, I consider treatment options that balance a strong safety profile with early and sustained symptom improvement,” she explained.

Looking Ahead: Further Research and Data Analysis

Organon plans to present further sub-analyses of the ADORING 1 and ADORING 2 trial data at the American Academy of Dermatology Annual Meeting later this year. These additional analyses will likely provide further insights into the benefits of tapinarof cream for various aspects of AD, including quality of life and disease-related burden. The company remains committed to disseminating clinically relevant data to healthcare providers and patients.

For more information, Druhan L. Howell, MD, and Rafael Chaves Cardona, MD, can be reached at [email protected].